Maintaining Vigilance Activity Compliance After the Departure of a Key Team Member

Context

A large medical device company was struggling to maintain all of its vigilance activities following the departure of the responsible person, in a difficult recruitment context.

The challenge

Every day without vigilance management represented a real risk: failure to detect a trend impacting clinical safety, risk of non-conformity in the event of an audit or inspection, and potential reputational impact with prescribers and patients.

The One Health Compliance solution

• Rapid analysis of the situation and definition of a solution taking into account available internal resources and a worst-case scenario: how to maintain compliance even in the absence of short-term recruitment?
• Verification of compliance with regulatory requirements and implementation of the necessary remediation activities.
• Creation of a reusable tool and simplified process to ensure continuity.

The result

• A simplified vigilance process and a tailored reusable tool.
• Corrective actions traced and justifiable during an audit or inspection.
• Immediate internalisation of activities and compliance with regulatory deadlines without waiting for recruitment.

✓ Compliance continuity ensured ✓ Reusable tool created ✓ Regulatory deadlines met

Does your situation share similarities with this case? Feel free to get in touch to discuss it.

Sandra Dejean, PharmD – Founder of One Health Compliance

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